NCT00258401

Low-Residue Diet in Treating Diarrhea in Patients Receiving Pelvic Radiation Therapy.

The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Eating a diet low in residue (fiber, fat, and certain milk or vegetable products) may help prevent or reduce diarrhea caused by pelvic radiation therapy. PURPOSE: This randomized clinical trial is studying a low-residue diet to see how well it works compared to no dietary intervention in treating diarrhea in patients who are undergoing radiation therapy to the pelvis for uterine, cervical, or prostate cancer.

Detailed description

OBJECTIVES: * Compare the nutritional status, Common Toxicity Criteria (CTC) score, and fecal incontinence quality of life (FI-QOL) in patients with uterine, cervical, or prostate cancer who are undergoing pelvic radiotherapy receiving a low-residue diet vs no dietary intervention. * Compare changes in the CTC score and FI-QOL in patients receiving a low-residue diet vs no dietary intervention. * Compare the efficacy, in terms of a lower CTC score or higher perceived FI-QOL, of a low-residue diet vs no dietary intervention in these patients. OUTLINE: This is a parallel, randomized, controlled, pilot study. Patients are stratified according to cancer type. Patients are randomized to 1 of 2 treatment arms. All patients are interviewed to obtain a baseline grade of diarrhea (according to NCI's Common Toxicity Criteria \[CTC\] scale) and dietary history and measure Fecal Incontinence Quality of Life (FI-QOL). * Arm I (intervention): At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks. They are interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores. * Arm II (control): Patients undergo no dietary intervention but are interviewed as in arm I. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Conditions

• Cervical Cancer
• Diarrhea
• Prostate Cancer
• Radiation Toxicity
• Sarcoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	dietary intervention	At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.
PROCEDURE	management of therapy complications	Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
PROCEDURE	quality-of-life assessment	Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-05-01
• Completion: 2006-06-01
• First posted: 2005-11-24
• Last updated: 2020-07-27

Locations

1 site across 1 country: United States